About this trial
The goal of this clinical trial is to demonstrate the efficacy of multi domain robotic and technological rehabilitation on everyday life and satisfaction in children with neuromotor conditions. The main questions it aims to answer are:
* Will we have significant changes using the COPM in children taking part in the sperimental group? * The children who will undergo the multidomain treatment will also experience functional improvements in individual areas? * Thy type of treatment will improve motivation, active participation and satisfaction in children?
Researcher will compare the multidomain treatment to standard care proposed by the included clinical centers: single domain rehabilitation with one innovative device. Both groups will undergo also conventional multidomain therapy.
This will be done to see if using a holistic approach, and including every need of the child in the rehabilitation plan, can lead to greater improvements in quality of life compared to the control group.
Participant will:
* Be evaluated 3 times with clinical outcome measures * Take part in a rehabilitation program, at least 20 x 2hours sessions treatment, organized in:
* 4 weeks, 5 times per week * 7 weeks, 3 times per week
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of developmental disorder and/or disability, either congenital or acquired;
Age between 5 and 21 years at the time of recruitment;
Verbal and/or non-verbal reasoning abilities > 70 or > 5th percentile, as assessed by standardized tests such as Colored Progressive Matrices (CPM), WISC-IV or WISC-V, WPPSI-III or WPPSI-IV, Leiter-3, Griffiths III.
Disqualifiers
Presence of severe comorbidities and/or behavioral/cognitive disorders that prevent adequate patient compliance with both conventional and robotic rehabilitation treatment (severe intellectual disability);
Uncontrolled epilepsy;
Presence of severe sensory deficits;
Patients who have undergone orthopedic functional surgery or rhizotomy and/or botulinum toxin treatment in the last 6 months;
Trial design
Parallel
Treatments tested in this trial
Multidomain intervention
Other interventiontreatment plan using combination of more than one technological or robotic devices, choosing from: Virtual Reality Rehabilitation System (VRSS), Khymeia TR; HomeKIT Khymeia; VRSS Khymeia EVO; Myro® Tyromotion; Diego Tyromotion; Tyrostation Tyromotion; Pablo® Tyromotion; Amadeo Tyromotion; Lexo® Tyromotion; Humaware MObile RoboT for upper Limb NeurOortho Rehabilitation (MOTORE); Humanware Upper Limb TRAcker(ULTRA+); Gloreha Sinfonia plus; C-Mill Motek; Gait Real Time Analysis Laboratory (GRAIL) Motek Medical; Nirvana BTS; Agilik; Armeo Spring pediatrico Hocoma; Lokomat ® Hocoma; Hand Tutor, Leg Tutor, Arm Tutor (MediTouch); Care Lab; Dessintey IVS3; Rehacom Hasomed; Hunova; GEO System (Kineo). In this way, the child will be taken care of holistically, considering their needs from a motor, cognitive, and speech therapy perspective. The treatment plan will also include a conventional multi-level rehabilitation program.
Single domain intervention
DeviceTreatment plan using only one of these technological or robotic device: Virtual Reality Rehabilitation System (VRSS), Khymeia TR; HomeKIT Khymeia; VRSS Khymeia EVO; Myro® Tyromotion; Diego Tyromotion; Tyrostation Tyromotion; Pablo® Tyromotion; Amadeo Tyromotion; Lexo® Tyromotion; Humaware MObile RoboT for upper Limb NeurOortho Rehabilitation (MOTORE); Humanware Upper Limb TRAcker(ULTRA+); Gloreha Sinfonia plus; C-Mill Motek; Gait Real Time Analysis Laboratory (GRAIL) Motek Medical; Nirvana BTS; Agilik; Armeo Spring pediatrico Hocoma; Lokomat ® Hocoma; Hand Tutor, Leg Tutor, Arm Tutor (MediTouch); Care Lab; Dessintey IVS3; Rehacom Hasomed; Hunova; GEO System (Kineo). Technological rehabilitation will focus on the main specific need for the child, it'll be chosen individually. The treatment plan will also include a conventional multi-level rehabilitation program.
Treatment groups
Trial outcomes
Primary outcomes
Canadian Occupational Performance Measure (COPM)
Assessment tool used in occupational therapy to evaluate an individual's performance and satisfaction in both daily and personal activities. The COPM focuses on activities that are meaningful to the assessed person, allowing them to identify areas where they wish to improve their abilities or participation. This tool helps therapists better understand their patients' needs and desires, enabling them to plan targeted therapeutic interventions to enhance their quality of life and overall well-being.
Secondary outcomes
Melbourne Assessment-2 (MA2)
A standardized, valid, and reliable tool for assessing the quality of upper limb movement in children with neurological deficits aged between 2.5 and 15 years. The MA2 measures four elements of movement quality: range of motion, accuracy, dexterity, and fluidity. It consists of 14 items for reaching, grasping, releasing, and manipulating simple objects. For each item the examiner gives a score ranging from 0 to 4, higher score corresponds to better performance.A raw score and percentage score are provided for each of the four sections, which will be analyzed separately. The test is administered by video recording the child's performance, which will be evaluated later by the examiner.
ABILHAND-Kids.
The ABILHAND-Kids is a brief questionnaire that measures 21 key bimanual daily activities. The score is assigned by a parent based on the difficulty the child has in performing the requested activity on a daily basis, using a 3-point scale (impossible, difficult, easy). The response scores are entered into a Rasch model to obtain a continuous score representing the child's level of manual ability. A higher score indicates greater manual skill and autonomy. It has been validated in children with Cerebral Palsy aged 6 to 15 years, showing good validity (R=0.94) and good reproducibility over time (R=0.91).
Gross Motor Function Measure-88 (GMFM-88).
The GMFM-88 is an assessment tool used to measure gross motor ability in children with motor disabilities, particularly those affected by cerebral palsy. It is designed to evaluate motor function in areas such as positioning, movement, trunk control, and locomotion. The GMFM-88 consists of a series of 88 items divided into five dimensions (A, B, C, D, E), with each item rated on a 4-point scale (0-3) that reflects the child's level of ability for that specific task. Single scores are summed to obtain a partial score for each dimension. The partial scores are then combined to calculate a total score, represented as a percentage that reflects the child's overall performance in gross motor skills. A higher score indicates better gross motor function.
Six Minutes Walking Test (6MWT)
A test used to assess walking endurance in children with cerebral palsy. During the test, the child is encouraged to walk as much as possible for a period of six minutes along a standardized pathway. The score is assigned based on the total distance covered in six minutes and the distance covered separately in each minute, expressed in meters. This distance is then interpreted according to normative tables that vary by age, gender, and sometimes health status to determine if the result is adequate, below average, or above average. This test provides valuable information about the child's level of endurance during walking and can be used to monitor progress over time and evaluate the effectiveness of therapeutic interventions.
Sponsors and contacts
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IRCCS Fondazione Stella Maris
Lead sponsor
IRCCS Eugenio Medea
Collaborator
Fondazione Don Carlo Gnocchi Onlus
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Istituto Giannina Gaslini
Collaborator